The company’s first data release on Monday was hit hours later through a rare reprimand from the government’s Data Safety Monitoring Board, an independent group that oversees vaccine manufacturers’ studies.
The group asked why, in mid-February, AstraZeneca was using “out of date information” from an interim analysis of the study data and outdated results showing slightly decreased but still strong effectiveness at the National Institute of Allergies and Infectious Diseases.
“The problem the DSMB had is straightforward and very simple: the DSMB had data that it knew the company had. When they saw the press release, they said, “Wait a minute – the data in the press release does not reflect the latest data that we know you have,” said NIAID Director Anthony Fauci at the time.
AstraZeneca defended itself by stating that the latest data was still “consistent” with the shared data. While the overall effectiveness decreased slightly, the effectiveness in people aged 65 and over increased from 80 to 85 percent. The company claimed Wednesday that its vaccine is 100 percent effective against serious illness and hospitalization, reflecting its earlier announcement.
The latest results Still rank AstraZeneca way above the Food and Drug Administration’s bar for approving a coronavirus vaccine – 50 percent effectiveness – for both adults overall and the elderly in particular. However, the confusion has sparked concerns that the public will lose confidence in the shot, despite the fact that AstraZeneca stands ready to ship tens of millions of cans to the US government. The company has announced that it will seek emergency approval for its vaccine from the Food and Drug Administration by mid-April.
The US excitement comes less than a week after the European Medicines Agency rushed to reassure member countries that the vaccine is safe and effective, amid unfounded fears that it will cause blood clots, adding 13 countries to the list causes its use to be discontinued.
AstraZeneca’s Wednesday update was released in the form of a press release from the company, as was Monday’s data – a practice that scientists criticized during the pandemic for providing an incomplete picture of test results. AstraZeneca announced that it will publish its results in a peer-reviewed scientific journal in the coming weeks.
“The primary analysis is consistent with our previously published interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 and over,” said Mene Pangalos, EVP of BioPharmaceuticals R&D, in a statement.
A spokesman said the company has 30 million doses available and could deliver 50 million more in the coming weeks, plus 15 to 20 million each month thereafter.
The Trump administration signed a contract with AstraZeneca to supply 300 million doses of its vaccine.